The Addition of rTMS to the Therapy of Adolescents That Suffer From Treatment Resistant Depression: An Open Label Study
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Child Depression Rating Scale (CDRS) comparison before after therapy
研究概览
简要总结
The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and effective add-on therapy for resistent depression in adolescent patients.
A group of adolescents suffering from non psychotic major depression that was resistant to at least 2 drug trials and a trail of psychotherapy will be recruited. After an informed consent procedure for both parents and patients, patients will go through a clinical and cognitive evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using the figure of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain interval of 30 sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 15-18 years old
- •Right hand dominant
- •Suffering from major depression
- •CDRS > 60
- •At least 3 months of current depressive episode
- •Failed 2 drug trials (or 3 drug trials if trial terminated prematurely due to side effects) and at least 1 course of psychotherapy
- •No contraindication for rtms (safety questionnaire)
- •No change in pharmacotherapy in the last month
排除标准
- •Schizophrenia or psychotic symptoms
- •Hypertension
- •History of major head trauma
- •Metal implements in the head
- •History of neurosurgery
- •History of severe head migraine
- •History of hearing loss or sp cochlear transplantation
- •Pregnancy
- •Current drug abuse
- •Unstable medical condition
- •History of manic episode
- •Current treatment with lithium or tricyclic or tetracyclic antidepressants
结局指标
主要结局
Child Depression Rating Scale (CDRS) comparison before after therapy
时间窗: 4 weeks
次要结局
未报告次要终点